South Korea

The primary regulatory authority for health products in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). The MFDS operates under the framework of several core legislative instruments, including the Pharmaceutical Affairs Act, the Medical Devices Act, and the In Vitro Diagnostics Medical Devices Act, each governing their respective product categories. Digital health and software as a medical device (SaMD) are regulated under guidelines aligned with the Medical Devices Act, with dedicated guidance issued in recent years to address artificial intelligence-based medical software. The approval process generally requires product registration prior to market entry, with the MFDS conducting scientific and technical review of submitted dossiers, GMP inspections of manufacturing facilities, and, where applicable, clinical evaluation of safety and efficacy data. Expedited pathways exist for innovative or urgently needed products, including conditional approval and priority review designations.

All applicants seeking market authorization in South Korea must appoint a local authorized representative or importer, as foreign manufacturers cannot apply directly without a domestic entity. Dossiers are accepted in formats aligned with the Common Technical Document (CTD) standard, and the MFDS participates in international harmonization efforts through the International Council for Harmonisation (ICH) and the Asian Harmonization Working Party (AHWP), accepting data packages that conform to these standards. South Korea has also implemented a reliance mechanism that allows abbreviated review based on prior approvals from recognized reference regulatory authorities such as the US FDA, EMA, and PMDA Japan, reducing duplication for globally approved products. Recent reforms include strengthened post-market surveillance requirements, mandatory unique device identification (UDI) registration for medical devices, and updated regulations for combination products and digital therapeutics, reflecting the MFDS commitment to adapting its frameworks to emerging health product categories.

Public procurement of health products in South Korea is coordinated through a structured national system involving multiple governmental bodies. The Ministry of Health and Welfare (MOHW) sets overarching health policy and determines which products are eligible for coverage under the National Health Insurance (NHI) scheme, administered by the National Health Insurance Service (NHIS). The Health Insurance Review and Assessment Service (HIRA) plays a critical role in evaluating the clinical and economic value of health products for reimbursement listing, using health technology assessment (HTA) processes that include cost-effectiveness analysis and budget impact assessments. Public hospitals and institutions procure medical products primarily through the Public Procurement Service (PPS), a central purchasing authority that manages government-wide procurement contracts and tenders. Pricing negotiation for pharmaceuticals and medical devices listed on the NHI formulary or device reimbursement list is conducted directly between manufacturers or their local representatives and the NHIS, following positive HTA recommendations from HIRA. Price controls and reference pricing mechanisms are applied to listed products, and annual price adjustments may occur based on market data and utilization reviews.

The private sector represents a significant share of the South Korean health market, with a large network of private hospitals, clinics, and pharmacies procuring products independently through local distributors and direct supplier agreements outside of NHI-listed channels. While South Korea is a high-income country and not a primary recipient of donor-funded health procurement programs such as those managed by UNICEF Supply Division, the Global Fund, USAID, or Gavi, these channels are not relevant to its domestic market in a meaningful way. South Korea does, however, actively support global health initiatives as a donor country and engages in bilateral health cooperation programs. In terms of local manufacturing preference, South Korea has implemented policies to support domestic pharmaceutical and medical device industries, including preferential treatment in public procurement for locally manufactured products under certain conditions, incentives for domestic production of essential medicines, and strategic investments in biopharmaceutical manufacturing capacity as part of its national industrial competitiveness agenda.